NCT00548483

Brief Summary

The specific objectives were to determine whether high dose dexamethasone are more effective than low dose dexamethasone in the reduction or prevention of post-extubation airway obstruction among patients with a cuff leak volume (CLV) \< 110 mL.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

May 28, 2008

Status Verified

May 1, 2008

Enrollment Period

11 months

First QC Date

October 23, 2007

Last Update Submit

May 27, 2008

Conditions

Airway Obstruction

Keywords

Endotracheal intubationLaryngeal edemaCuff-leak testCorticosteroidsThis study was to ascertain whether administration of dexamethasone to critically intubated patients prevent postextubation airway obstruction.This study was to compare high dose and low dose dexamethasone in preventing noninvasive ventilation or reintubation among critically ill intubated patients

Outcome Measures

Primary Outcomes (1)

  • absolute cuff leak volumes and relative cuff leak volume to tidal volume(%)(measured CLV-baseline CLV) X 100/ tidal volume)

    48 hours

Study Arms (2)

1

ACTIVE COMPARATOR

dexamethasone 5mg was administered every 6 hour for 1 day

Drug: dexamethasone (Oradexon, Nederland)

2

ACTIVE COMPARATOR

dexamethasone 10mg was administered every 6 hour for 1 day

Drug: dexamethasone (Oradexon, Nederland)

Interventions

dexamethasone (Oradexon, Nederland)DRUG

dexamethasone 5mg was administered every 6 hour for 1 day in group 1 and dexamethasone 10mg was administered every 6 hour for 1 day in group 2

12

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients were \> 18 years of age and met the following weaning criteria:
  • Temperature ≤ 38°C for \> 8 hours,
  • Discontinuous use of sedatives,
  • Heart rate ≥ 70 and ≤ 130 /min,
  • Systolic blood pressure (SBP) ≥ 80 mm Hg in the absence of vasopressors,
  • Fraction of inspired oxygen (FiO2) ≤ 0.6, PaO2 ≥ 60, and partial pressure of oxygen (PaO2)/FiO2 ratio \> 200,
  • Positive end-expiratory pressure (PEEP) ≤ 5 cm H2O,
  • Rapid and shallow ratio of frequency to tidal volume (f/VT ≤ 105),
  • Minute ventilation ≤ 15 L/min, and
  • pH ≥ 7.3. Supplemental oxygen was continued to maintain an oxygen saturation \> 95% as measured by a pulse oximeter.

You may not qualify if:

  • A history of extubation during the same hospitalization
  • Administration of corticosteroids seven days prior to extubation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

No. 92, SEC. 2, CHUNG SHAN N. RD, TAIPEI, TAIWAN.

Taipei, 104, Taiwan

RECRUITING

Related Publications (3)

  • Lee CH, Peng MJ, Wu CL. Dexamethasone to prevent postextubation airway obstruction in adults: a prospective, randomized, double-blind, placebo-controlled study. Crit Care. 2007;11(4):R72. doi: 10.1186/cc5957.

    PMID: 17605780BACKGROUND

  • Cheng KC, Hou CC, Huang HC, Lin SC, Zhang H. Intravenous injection of methylprednisolone reduces the incidence of postextubation stridor in intensive care unit patients. Crit Care Med. 2006 May;34(5):1345-50. doi: 10.1097/01.CCM.0000214678.92134.BD.

    PMID: 16540947BACKGROUND

  • Francois B, Bellissant E, Gissot V, Desachy A, Normand S, Boulain T, Brenet O, Preux PM, Vignon P; Association des Reanimateurs du Centre-Ouest (ARCO). 12-h pretreatment with methylprednisolone versus placebo for prevention of postextubation laryngeal oedema: a randomised double-blind trial. Lancet. 2007 Mar 31;369(9567):1083-9. doi: 10.1016/S0140-6736(07)60526-1.

    PMID: 17398307BACKGROUND

MeSH Terms

Conditions

Airway ObstructionLaryngeal Edema

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesLaryngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Chao-Hsien Lee, MD

    Mackay Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chao-Hsien Lee, MD

CONTACT

+886-2-23926589L49428@ms2.mmh.org.tw

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 23, 2007

First Posted

October 24, 2007

Study Start

April 1, 2007

Primary Completion

March 1, 2008

Study Completion

May 1, 2008

Last Updated

May 28, 2008

Record last verified: 2008-05

Locations

TW(1)